Windstone Medical Packaging, Inc.: General Surgery Tray
Recall Summary Windstone Medical Packaging is recalling 17 different surgical instrument trays (ENT, rhinoplasty, spine, and other procedure packs) distributed nationwide because they contain Ritmed Neurological Sponges with potentially inconsistent endotoxin levels. Endotoxins are bacterial substances that can cause adverse reactions if present in unexpected amounts on medical devices. These kits were distributed to healthcare facilities across most U.S. states.
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pack, Part Number AMS12636C; 5) Lumbar Lami Pack, Part Number AMS12731; 6) Septoplasty Pack, Part Number AMS13150; 7) Septoplasty Pack, Part Number AMS13150A; 8) Septoplasty Pack, Part Number AMS13150B; 9) Rhinoplasty Pack, Part Number AMS14496A; 10) Rhinoplasty Pack, Part Number AMS14496B; 11) Rhinoplasty Pack, Part Number AMS14496C; 12) Laryngoscopy Pack, Part Number AMS14736; 13) Nasal and Sinus...
- Reason
- The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/65969059-e30f-4c5b-9c5a-0e5a8665051d